FDA publishes draft guidance on BR assessment including patient perspective

The FDA published a draft guidance on “Factors to Consider Regarding Benefit- 11 Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions”. Notably it contains a section called “How FDA Considers Benefit-Risk in Patient Focused Medical Device Product Availability, Compliance, and Enforcement Decisions”. It also discusses patient preferences on the benefit, patient tolerances of risk, patient impact, and patient preferences for availability.